Actively Recruiting

Age: 18Years - 99Years
FEMALE
NCT06650423

Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer

Led by Institute of Oncology Ljubljana · Updated on 2026-03-06

319

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

I

Institute of Oncology Ljubljana

Lead Sponsor

U

University of Ljubljana

Collaborating Sponsor

AI-Summary

What this Trial Is About

Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-). Despite advancements in adjuvant endocrine therapy, 20-30% of early-stage breast cancer patients relapse within the first decade post-surgery. A recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4/6 inhibitors (CDK4/6 inhibitors). Abemaciclib and ribociclib were assessed in the adjuvant setting, both showing improvement in invasive disease-free survival (IDFS). Abemaciclib has been approved by the FDA and EMA for HR+/HER2- early breast cancer at high risk of disease recurrence and is the first addition to the Slovenian treatment regimen in routine clinical practice. Poor medication adherence can directly affect the effectiveness of treatment for early HR+/HER2- breast cancer. While adherence data in patients treated with aromatase inhibitors are available, the adherence rate in patients with early HR+/HER2- breast cancer taking abemaciclib remains unclear. In this study, investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have lower medication adherence and higher discontinuation rates compared to those receiving aromatase inhibitors alone. It is expected that patients with better quality of life, better cognitive functioning, and a more positive attitude toward their therapy will demonstrate higher medication adherence rates. Adherence may also be influenced by additional factors, such as age and prior treatments.

CONDITIONS

Official Title

Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Diagnosed with early hormone receptor-positive and HER2-negative breast cancer
  • Currently receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole, or exemestane), with or without abemaciclib, for no more than 18 months
  • Treatment is being conducted at the Oncology Institute of Ljubljana
  • Has mandatory health insurance through the Health Insurance Institute of Slovenia
  • Understands Slovenian language
  • Agrees to participate and provides written informed consent
Not Eligible

You will not qualify if you...

  • Has metastatic hormone receptor-positive and HER2-negative breast cancer
  • Previously treated for breast cancer with an aromatase inhibitor, with or without a CDK4/6 inhibitor, before the current adjuvant treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

E

Erika Matos, PhD

CONTACT

C

Cvetka Grašič Kuhar, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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